Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
900 participants
INTERVENTIONAL
2022-07-04
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HIV-exposed neonates
Point-of-care HIV testing at birth
Point-of-Care Cepheid Xpert HIV-1
Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.
HIV-positive infants identified through birth HIV screening
Early antiretroviral treatment per standard of care, including dolutegravir-based regimen beginning at 4 weeks of age for infants weighing at least 3.0kg.
DTG/ABC/3TC
Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.
Interventions
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Point-of-Care Cepheid Xpert HIV-1
Post-partum HIV-positive women with pre-determined risk factors for vertical HIV transmission will be offered point-of-care HIV testing for their newborns for early infant HIV diagnosis.
DTG/ABC/3TC
Infants will be started on a combination of NVP/ZDV/3TC. A switch to DTG/ABC/3TC will occur for all infants at or after 4 weeks (28 days) post-delivery for those weighing ≥3kg. Dosing of all ART will be weight-based by the Botswana treatment guidelines.
Eligibility Criteria
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Inclusion Criteria
2. Mother willing and able to provide verbal consent for infant testing
3. Infant birth weight ≥1.5kg
4. Presence of any of the following risk factors:
\<12 weeks of ART prior to delivery (including no ART); Known HIV-1 viremia (above level of detection) for last test performed or at any time \>24 weeks gestation in pregnancy; CD4 cell count known to be \<350 cells/mm3 within the past year; Self-described poor adherence in pregnancy (1 or more complete days of missed ART)
1. Mother 18 years of age or older
2. Mother willing and able to provide written informed consent for study participation for herself and her infant
3. Positive point-of-care HIV screening for infant (HIV DNA PCR pending or completed)
4. Infant eligible for ART treatment in accordance with the Botswana government program
5. Infant birth weight ≥1.5 kg
Exclusion Criteria
1. Medical condition making it unlikely that the infant will survive to 24 months
2. Infant unable to start treatment-dose ART \< 168 hours of age
3. Infant unable to attend follow-up visits at a BHP study clinic in Gaborone or Francistown
ALL
No
Sponsors
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Botswana Harvard AIDS Institute Partnership
OTHER
Ragon Institute of MGH, MIT and Harvard
OTHER
Botswana Ministry of Health
OTHER_GOV
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Roger Shapiro
Associate Professor of Immunology and Infectious Diseases
Principal Investigators
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Roger L Shapiro, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)
Locations
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Botswana Harvard HIV/AIDS Institute Partnership
Gaborone, , Botswana
Countries
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Other Identifiers
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155BHP
Identifier Type: -
Identifier Source: org_study_id